Cardium Reports on Recent Norwegian Study Revealing That History of Foot...

SAN DIEGO, Dec. 16 /PRNewswire-FirstCall/ -- Cardium
Therapeutics (NYSE Amex: CXM) today reported on recent clinical
findings published in the December issue of Diabetes Care showing
an increase in mortality in diabetic patients with a history of
foot ulcer (HFU) compared with diabetic patients without HFU and
with non-diabetic patients.

The study titled, "A history of foot ulcer increases mortality
among persons with diabetes. 10-year follow-up of the
Nord-Trondelag Health Study, Norway", (Diabetes Care. 2009
Dec;32(12): 2193-9. Epub 2009 Sep 3) followed 63,632 non-diabetic
individuals, 1,339 diabetic patients without a history of foot
ulcers, and 155 diabetic patients with a history of foot ulcers for
10 years with mortality as the endpoint. During the 10-year
period, 49.0% of adults with diabetes and a history of foot ulcers
died compared to 35.2% with diabetes and no HFU and 10.5% without
diabetes. With adjustments for lifestyle and demographic
factors, diabetic patients with HFU were more than two times more
likely to die during the follow up period than the subjects that
were non-diabetic. Comparing diabetic individuals, a HFU was
associated with 47% increased mortality. The increased risk
persisted after adjustment for co-morbidity and depression
scores.

The prevalence of diabetes is rapidly increasing and it is
predicted that by the year 2025, an estimated 300 million people in
the world will have the disease. One of the most common
complications of diabetes is the development of lower extremity
ulcers and in the U.S. about 15% of the almost 24 million
diabetics, or 3.6 million people, will develop these
wounds.

"This new study shows that a history of diabetic foot ulcers is
a predictor of mortality in diabetic patients. In addition to
finding new ways to educate diabetic patients on how to avoid
developing ulcers, it is also important to provide health care
providers with a wide array of advanced care technologies to treat
these wounds when they do occur. We recently announced
the submission of our FDA 510(k) premarket notification of our
Excellagen collagen protein-based wound management product
candidate, which represents an important step forward in the
commercialization of our Excellagen technology platform. Our
advanced wound healing technology platform also involves Cardium's
Gene Activated Matrix technology which covers DNA-based wound
healing, as well as DNA-based orthobiologics," reported Christopher
J. Reinhard, Cardium's Chairman and Chief Executive Officer.

Gene Activated Matrix Technology Platform

Cardium recently reported on data from the Matrix Phase 2b
clinical trial of Excellarate™ for the potential treatment of
patients with chronic non-healing diabetic foot ulcers based on its
Gene Activated Matrix technology platform. The study
evaluated patients treated with the Excellarate product candidate
(combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone
compared to patients who received only the protocol specified
standard of care. Nearly half of patients (48%) receiving a
one-time Excellarate treatment had complete wound closure by 12
weeks, compared to a 31% wound closure rate for standard of
care. Among combined one and two dose groups of Excellarate
approximately 41% of patients achieved complete closure by 12
weeks. The Company plans to schedule a meeting with the FDA
in early 2010 to review the complete integrated data set and
outline plans for a Phase 3 clinical study program designed to
confirm the safety and effectiveness of Excellarate as compared to
standard of care, since PDGF-B is known to contribute to the
biologic process of wound healing and is itself an approved protein
product for use in advanced wound care. Cardium believes that
the combination of collagen and PDGF-B as provided by the
Excellarate product candidate holds the potential to further
promote wound healing in non-healing diabetic foot ulcers and other
difficult-to-treat wounds.

On December 3, 2009, the Company filed a 510(k) premarket
notification with the U.S. Food and Drug Administration (FDA)
seeking marketing clearance of its Excellagen™ product
candidate based in part on the positive data from the Company's
Phase 2b clinical trial that demonstrated substantial improvements
in wound healing responses in patients with non-healing diabetic
foot ulcers following one or two applications of Excellagen.
Excellagen™ is an advanced wound care device composed of
highly-refined, soluble bovine dermal collagen (Type I), which is
modified to reduce immunogenicity and promote its usefulness in
wound settings. Excellagen is designed for use by health care
professionals in patients with dermal wounds, which can include
diabetic ulcers, pressure ulcers, venous ulcers,
tunneled/undermined wounds, surgical and trauma wounds, second
degree burns, and other types of wounds. The Company plans to
develop additional new product opportunities by incorporating other
agents into Excellagen formulations, including antimicrobials, DNA
and/or other biologics, which are designed to address particular
wound healing and other tissue repair applications.

About Cardium

Cardium is focused on the acquisition and strategic development
of new and innovative bio-medical product opportunities and
businesses that have the potential to address significant unmet
medical needs and definable pathways to commercialization,
partnering and other economic monetizations. Cardium's
investment portfolio includes the Tissue Repair Company and Cardium
Biologics, medical technology companies primarily focused on the
development of innovative therapeutic products for wound healing,
bone repair, and cardiovascular indications. In July 2009,
Cardium completed the sale of its InnerCool Therapies medical
device business to Royal Philips Electronics, the first asset
monetization from the Company's biomedical investment
portfolio. News from Cardium is located at www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed
in this press release are forward looking and reflect numerous
assumptions and involve a variety of risks and uncertainties, many
of which are beyond our control and may cause actual results to
differ materially from stated expectations. For example,
there can be no assurance that the U.S. Food and Drug
Administration will grant marketing clearance of the
ExcellagenXL™ and ExcellagenFX™ product candidates or
that we can successfully introduce these or additional products
into advanced wound care markets; that Excellagen, Excellarate or
our other candidates will prove to be sufficiently safe and
effective, or that results or trends observed in one clinical study
or procedure will be reproduced in subsequent studies or
procedures, or that clinical studies even if successful will lead
to product advancement or partnering; that the Excellagen or
Excellarate product candidate offers the potential for simpler or
more cost-effective treatment for physicians and patients than
other FDA-approved products that currently are or will be on the
market; that the Matrix clinical study program or other human
clinical trials can be conducted and completed in an efficient and
successful manner; that we can develop a DNA-based orthobiologics
product portfolio; that our products or product candidates will not
be unfavorably compared to competitive products that may be
regarded as safer, more effective, easier to use or less expensive;
that FDA or other regulatory clearances or other certifications, or
other commercialization efforts will be successful or will
effectively enhance our businesses or their market value; that our
products or product candidates will prove to be sufficiently safe
and effective after introduction into a broader patient population;
or that third parties on whom we depend will perform as
anticipated.

Actual results may also differ substantially from those
described in or contemplated by this press release due to risks and
uncertainties that exist in our operations and business
environment, including, without limitation, risks and uncertainties
that are inherent in the development of complex biologics and in
the conduct of human clinical trials, including the timing, costs
and outcomes of such trials, our ability to obtain necessary
funding, regulatory approvals and expected qualifications, our
dependence upon proprietary technology, our history of operating
losses and accumulated deficits, our reliance on collaborative
relationships and critical personnel, and current and future
competition, as well as other risks described from time to time in
filings we make with the Securities and Exchange Commission.
We undertake no obligation to release publicly the results of any
revisions to these forward-looking statements to reflect events or
circumstances arising after the date hereof.